CirrhosisEvenciporNCT04807803
Evaluation of Minimal Hepatic Encephalopathy in Patients With Cirrhosis and Portal Hypertension
A study testing Assessment of Minimal hepatic encephalopathy (MHE) in people with Cirrhosis and Portal Hypertension, run by IHU Strasbourg at 2 sites in France.
Trial summary
Minimal hepatic encephalopathy (MHE) is a subclinical cognitive impairment and represents the mildest type of hepatic encephalopathy (HE). Portal hypertension is the main complication of cirrhosis and is responsible of severe complications such as HE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Portal Hypertension
- What is being tested?
- Assessment of Minimal hepatic encephalopathy (MHE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Mar 2021to 24 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with cirrhosis and portal hypertension older than 18 old
- Patient who underwent a CT scan or MRI in the last 3 months
- The Mini-Mental State (MMS) test >25.
- Patient capable of receiving and understanding information relating to the study and of giving his written informed consent.
- Patient affiliated to the French social security system
Who cannot join
- Cirrhotic patient with overt HE or history of persistent or recurrent HE.
- Hepatocellular carcinoma beyond Milan criteria.
- Portal vein thrombosis.
- Previous transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt.
- Presence of neurological or psychiatric disorder.
- Patient with treatment by benzodiazepines or opioid substitution.
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- Pregnant or nursing women
- Patient in exclusion period of a previous study
- Patient under guardianship, trusteeship or the protection of justice or incapable of giving their own informed consent
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service d'Hépato-Gastroentérologie, Hôpitaux Civils
Colmar, 68024
Service d'Hépato-gastroentérologie, NHC
Strasbourg, 67000
About this study
Minimal hepatic encephalopathy (MHE) is a subclinical cognitive impairment and represents the mildest type of hepatic encephalopathy (HE). Portal hypertension is the main complication of cirrhosis and is responsible of severe complications such as HE. The consequence of portal hypertension is the formation of the spontaneous portosystemic shunts (SPSS). The relationship between the SPSS and their characteristics and the prevalence of MHE in patient with cirrhosis is poorly known. The main objective of this study is to evaluate the MHE in patients with cirrhosis and portal hypertension.
Read the detailed description
Minimal hepatic encephalopathy (MHE) is a subclinical cognitive impairment and represents the mildest type of hepatic encephalopathy (HE). It is a frequent complication of the liver disease, affecting up to 80% of tested patients. MHE affects severely the lives of patients by altering their quality-of-life and their socioeconomic status and is strongly associated to the development of overt HE. Portal hypertension is the main complication of cirrhosis and is responsible of severe complications such as HE. The consequence of portal hypertension is the formation of the spontaneous portosystemic shunts (SPSS). Their presence has been associated with recurrent or persistent HE. The relationship between the SPSS and their characteristics and the prevalence of MHE in patient with cirrhosis is poorly known.
Patients with compensated cirrhosis and portal hypertension will be considered for inclusion. After written inform consent, the serum ammonia, psychometric hepatic encephalopathy score (PHES) and the animal naming test (ANT) will be performed to evaluate the presence of MHE. Patients diagnosed with MHE will be treated and a new evaluation will be performed 6 months later.
- Conditions
- Cirrhosis, Portal Hypertension
- Being tested
- Assessment of Minimal hepatic encephalopathy (MHE)
- Keywords
- cirrhosis, portal hypertension, minimal hepatic encephalopathy, spontaneous portosystemic shunts, sarcopenia, myosteatosis
- Medical subject headings
- Fibrosis, Hypertension, Portal, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Minimal hepatic encephalopathy (MHE)Diagnostic test
Assessment of MHE at the inclusion and 6 months after treatment if diagnosed with MHE: Serum ammonia analysis, psychometric hepatic encephalopathy score (PHES), animal naming test (ANT) and evaluation of abdominal imaging, liver and splenic transient elastography, gastroscopy
| Study group | Role | What they receive |
|---|---|---|
| Patients with compensated cirrhosis and portal hypertension | Experimental | Not described Receives: Diagnostic Test: Assessment of Minimal hepatic encephalopathy (MHE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of MHE in patients with cirrhosis and portal hypertension by serum ammonia analysis
The serum ammonia analysis measures the level of ammonia in the blood, expressed in micromoles per liter. Average values in venous blood are between 11,2 and 48,2 micromoles per liter.
Measured: Day 1
Evaluation of MHE in patients with cirrhosis and portal hypertension by the psychometric hepatic encephalopathy score (PHES)
The psychometric hepatic encephalopathy score (PHES) is composed of five tests, number connection test-A (NCT-A), number connection test-B (NCT-B), serial dotting test (SDT), line tracing test (LTT) and digit symbol test (DST). The results of the NCT-A, NCT-B, and SDT were measured as seconds, including the time needed to correct any errors, and the result of DST was measured as points. The results of the LTT were measured as both the time needed to complete the test (LTTt, seconds) and as the error score (LTTe), LTT = (1 + LTTe/100) × LTTt. Accordingly, a higher result of DST equals better performance, and lower results on the other tests equal better performance.
The final score of PHES is generated from the sum of the scores of five tests, which ranged between +5 and -15. The result of the PHES is expressed in number of standard deviations (SD) from a population matched on age and level of education. A threshold (- 4DS) defines the EHM according to current recommendations.
Measured: Day 1
Evaluation of MHE in patients with cirrhosis and portal hypertension by the animal naming test (ANT)
The animal naming test (ANT) is an analysis of semantic fluency consisting of saying as many animal names as possible within one minute. The French recommendations developed by the French Association for The Liver Study (AFEF) suggests a limit of 20 animal names in 1 min. Below, the existence of MHE is likely.
Measured: Day 1
Secondary outcomes (8)
Evaluation of the correlation between MHE and portal hypertension by the mean of blood test and abdominal imaging
Portal hypertension will be qualitatively assessed (presence/absence) by blood tests (Plaquettes < 150 000 /mm3) and abdominal imaging (contrast-enhanced abdominal computed tomography (CT) or abdominal magnetic resonance imaging (MRI))
Measured: 1 month
Evaluation of the correlation between MHE and splenic congestion by elastography
Splenic congestion will be qualitatively assessed (presence/absence) by splenic elastography (≥ 52 kPa)
Measured: Day 1
Evaluation of the correlation between MHE and liver fibrosis by elastography
Liver fibrosis will be qualitatively assessed (presence/absence) by liver transient elastography (fibroscan > 14 kPa)
Measured: Day 1
Evaluation of the correlation between MHE and sarcopenia by imaging
Sarcopenia will be qualitatively assessed (presence/absence) by L3 Skeletal muscle index (L3 SMI) measured by CT scan: the muscle area at L3 vertebra level. The threshold values that define sarcopenia are: <50 cm² / m² for men and <39 cm² / m² for women.
Measured: Day 1
Evaluation of the correlation between MHE and myosteatosis by imaging
Myosteatosis is defined by muscle attenuation on CT scan which reflects fatty infiltration muscular. The average muscle attenuation will be reported for the calculated muscle area with sectional image similar to that provided to calculate the L3 SMI. The definition of the myosteatosis is <41 Hounsfield Unit (HU) for a BMI ≤ 24.9 kg / m² and ≥ 33 HU for patients with a BMI ≥ 25 kg / m².
Measured: Day 1
Evaluation of the neurologic assessment in patients diagnosed with MHE after 6 months of treatment by serum ammonia analysis
The serum ammonia analysis measures the level of ammonia in the blood, expressed in micromoles per liter. Average values in venous blood are between 14 and 38 micromoles per liter.
Measured: Month 7
Evaluation of the neurologic assessment in patients diagnosed with MHE after 6 months of treatment by the psychometric hepatic encephalopathy score (PHES)
The psychometric hepatic encephalopathy score (PHES) is composed of five tests, number connection test-A (NCT-A), number connection test-B (NCT-B), serial dotting test (SDT), line tracing test (LTT) and digit symbol test (DST). The results of the NCT-A, NCT-B, and SDT were measured as seconds, including the time needed to correct any errors, and the result of DST was measured as points. The results of the LTT were measured as both the time needed to complete the test (LTTt, seconds) and as the error score (LTTe), LTT = (1 + LTTe/100) × LTTt. Accordingly, a higher result of DST equals better performance, and lower results on the other tests equal better performance.
The final score of PHES is generated from the sum of the scores of five tests, which ranged between +5 and -15. The result of the PHES is expressed in number of standard deviations (SD) from a population matched on age and level of education. A threshold (- 4DS) defines the EHM according to current recommendations.
Measured: Month 7
Evaluation of the neurologic assessment in patients diagnosed with MHE after 6 months of treatment by the animal naming test (ANT)
The animal naming test (ANT) is an analysis of semantic fluency consisting of saying as many animal names as possible within one minute. The French recommendations developed by the French Association for The Liver Study (AFEF) suggests a limit of 20 animal names in 1 min. Below, the existence of MHE is likely.
Measured: Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start26 Mar 2021
- Primary completion24 Mar 2025
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simona TRIPON, MD, PhD, Principal investigator, Service d'Hépato-Gastroentérologie, NHC, Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807803
- Sponsor's protocol ID
- 19-010
- Acronym
- Evencipor
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2021
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Minimal Hepatic Encephalopathy in Patients With Cirrhosis and Portal Hypertension
- ClinicalTrials.gov ID
- NCT04807803
- Acronym / sponsor ID
- Evencipor / 19-010
- Conditions
- Cirrhosis, Portal Hypertension
- Keywords
- cirrhosis, portal hypertension, minimal hepatic encephalopathy, spontaneous portosystemic shunts, sarcopenia, myosteatosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Minimal hepatic encephalopathy (MHE) is a subclinical cognitive impairment and represents the mildest type of hepatic encephalopathy (HE). Portal hypertension is the main complication of cirrhosis and is responsible of severe complications such as HE. The consequence of portal hypertension is the formation of the spontaneous portosystemic shunts (SPSS). The relationship between the SPSS and their characteristics and the prevalence of MHE in patient with cirrhosis is poorly known. The main objective of this study is to evaluate the MHE in patients with cirrhosis and portal hypertension.
Detailed description
Minimal hepatic encephalopathy (MHE) is a subclinical cognitive impairment and represents the mildest type of hepatic encephalopathy (HE). It is a frequent complication of the liver disease, affecting up to 80% of tested patients. MHE affects severely the lives of patients by altering their quality-of-life and their socioeconomic status and is strongly associated to the development of overt HE. Portal hypertension is the main complication of cirrhosis and is responsible of severe complications such as HE. The consequence of portal hypertension is the formation of the spontaneous portosystemic shunts (SPSS). Their presence has been associated with recurrent or persistent HE. The relationship between the SPSS and their characteristics and the prevalence of MHE in patient with cirrhosis is poorly known.
Patients with compensated cirrhosis and portal hypertension will be considered for inclusion. After written inform consent, the serum ammonia, psychometric hepatic encephalopathy score (PHES) and the animal naming test (ANT) will be performed to evaluate the presence of MHE. Patients diagnosed with MHE will be treated and a new evaluation will be performed 6 months later.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with compensated cirrhosis and portal hypertension | Experimental | Diagnostic Test: Assessment of Minimal hepatic encephalopathy (MHE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with cirrhosis and portal hypertension older than 18 old
- Patient who underwent a CT scan or MRI in the last 3 months
- The Mini-Mental State (MMS) test >25.
- Patient capable of receiving and understanding information relating to the study and of giving his written informed consent.
- Patient affiliated to the French social security system
Key exclusion criteria (9 listed)
- Cirrhotic patient with overt HE or history of persistent or recurrent HE.
- Hepatocellular carcinoma beyond Milan criteria.
- Portal vein thrombosis.
- Previous transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt.
- Presence of neurological or psychiatric disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of Minimal hepatic encephalopathy (MHE)Assessment of MHE at the inclusion and 6 months after treatment if diagnosed with MHE: Serum ammonia analysis, psychometric hepatic encephalopathy score (PHES), animal naming test (ANT) and evaluation of abdominal imaging, liver and splenic transient elastography, gastroscopy | Diagnostic test | Patients with compensated cirrhosis and portal hypertension |
Primary outcome
Evaluation of MHE in patients with cirrhosis and portal hypertension by serum ammonia analysis
Time frame: Day 1
The serum ammonia analysis measures the level of ammonia in the blood, expressed in micromoles per liter. Average values in venous blood are between 11,2 and 48,2 micromoles per liter.
Evaluation of MHE in patients with cirrhosis and portal hypertension by the psychometric hepatic encephalopathy score (PHES)
Time frame: Day 1
The psychometric hepatic encephalopathy score (PHES) is composed of five tests, number connection test-A (NCT-A), number connection test-B (NCT-B), serial dotting test (SDT), line tracing test (LTT) and digit symbol test (DST). The results of the NCT-A, NCT-B, and SDT were measured as seconds, including the time needed to correct any errors, and the result of DST was measured as points. The results of the LTT were measured as both the time needed to complete the test (LTTt, seconds) and as the error score (LTTe), LTT = (1 + LTTe/100) × LTTt. Accordingly, a higher result of DST equals better performance, and lower results on the other tests equal better performance. The final score of PHES is generated from the sum of the scores of five tests, which ranged between +5 and -15. The result of the PHES is expressed in number of standard deviations (SD) from a population matched on age and level of education. A threshold (- 4DS) defines the EHM according to current recommendations.
Evaluation of MHE in patients with cirrhosis and portal hypertension by the animal naming test (ANT)
Time frame: Day 1
The animal naming test (ANT) is an analysis of semantic fluency consisting of saying as many animal names as possible within one minute. The French recommendations developed by the French Association for The Liver Study (AFEF) suggests a limit of 20 animal names in 1 min. Below, the existence of MHE is likely.
8 secondary outcomes
Evaluation of the correlation between MHE and portal hypertension by the mean of blood test and abdominal imaging
Time frame: 1 month
Evaluation of the correlation between MHE and splenic congestion by elastography
Time frame: Day 1
Evaluation of the correlation between MHE and liver fibrosis by elastography
Time frame: Day 1
Evaluation of the correlation between MHE and sarcopenia by imaging
Time frame: Day 1
Evaluation of the correlation between MHE and myosteatosis by imaging
Time frame: Day 1
Evaluation of the neurologic assessment in patients diagnosed with MHE after 6 months of treatment by serum ammonia analysis
Time frame: Month 7
Evaluation of the neurologic assessment in patients diagnosed with MHE after 6 months of treatment by the psychometric hepatic encephalopathy score (PHES)
Time frame: Month 7
Evaluation of the neurologic assessment in patients diagnosed with MHE after 6 months of treatment by the animal naming test (ANT)
Time frame: Month 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simona TRIPON, MD, PhD principal investigator
Service d'Hépato-Gastroentérologie, NHC, Strasbourg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of Minimal hepatic encephalopathy (MHE) in people with Cirrhosis and Portal Hypertension, run by IHU Strasbourg at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of MHE in patients with cirrhosis and portal hypertension by serum ammonia analysis (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.